Many men have non-functioning or malfunctioning urethral sphincters because of congenital malformations, trauma to the sphincter nerves or muscles, or disease of the sphincter nerves or muscles. A properly functioning urethral sphincter retains urine in the bladder until the sphincter is voluntarily relaxed which permits the urine to be discharged. When the urethral sphincter fails to function properly, uncontrolled drainage of urine from the bladder can occur. Obviously, this can be embarrassing to the individual and it can restrict his activities.
Numerous attempts have been made in the past to provide an artificial sphincter which can serve as a substitute for a malfunctioning urethral sphincter. Two such devices have enjoyed some commercial success. The first, the Rosen Inflatable Urinary Incontinence Prosthesis is described in Rosen et al U.S. Pat. No. 3,903,894, and the second, a more complex hydraulic device, is described in the Buuck et al. U.S. Pat. No. 3,863,622. The use of both of these devices has not been without problems and their acceptance has been limited.
There also have been attempts made to use simpler, less complex, external penile clamps to control male incontinence. Representative of such devices are the so-called Cunningham clamp which has been available since the 1920's and the devices shown in Foley U.S. Pat. Nos. 2,455,859 and 2,533,924. The primary disadvantage of the external penile clamps is that they cut off the major blood and nerve supplies to the penis and interfere with lymphatic drainage. As a result, congestion, edema, pain, inflammation and tissue erosion of the penis can result.